Prevention of Steroid-Induced Osteoporosis in Children
The purpose of this study is to determine whether the drug pamidronate can safely and effectively improve bone mineral density in growing children who have bone disease caused by taking steroid medications. People who take steroid medications called glucocorticoids, like prednisone or dexamethasone, for long periods almost always have decreased bone density and are at increased risk of breaking a bone. Research has shown that pamidronate improves bone density in adults who take glucocorticoids. However, use of pamidronate is not approved in children because it has not been extensively tested in children. It is possible that children will have a different response or unique problems with the medication because their bones are still growing. We will assign all study participants to one of two groups. One group will receive pamidronate intravenously (through a vein) every 3 months in addition of daily oral calcium and vitamin D and the other group will receive calcium and vitamin D. The study is scheduled to run for 36 months, with visits to the study center once every 3 months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prevention of Steroid-Induced Osteoporosis in Children|
- Lumbar spine BMD determined by DEXA [ Time Frame: Measured at Month 24 ]
- BMD of the spine, proximal femur BMD and volumetric BMD, total body bone mineral content (BMC), fracture incidence, bone turnover markers, and growth and skeletal changes [ Time Frame: Measured at Month 24 ]
|Study Completion Date:||September 2005|
This is a randomized study to determine whether pamidronate can safely and effectively improve bone mineral density (BMD) in children with glucocorticoid-induced osteoporosis. After we stratify participants on the basis of whether they are taking glucocorticoids for treatment of inflammatory disease or for immunosuppression following organ transplant, we will randomize them to receive daily calcium and vitamin D in addition to 30 mg/kg (1 mg/kg for weight less then 30 kg) of pamidronate in normal saline every 3 months or daily calcium and vitamin D only for 24 months, followed by a 12-month followup period off of therapy. We will measure endpoints at 24 months. The primary endpoint is lumbar spine BMD determined by DEXA. Secondary endpoints will include volumetric BMD of the spine, proximal femur BMD and volumetric BMD, total body bone mineral content (BMC), fracture incidence, bone turnover markers, and growth and skeletal changes. The study radiologist will be blinded to treatment group.
|United States, Missouri|
|Washington University Medical School-St. Louis Children's Hospital|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Rebecca P. Green, MD, PhD||Washington University Medical School-St. Louis Children's Hospital|